On December 30, 2010, EPA announced a settlement under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) with Crocs, Inc., the company famous for its ubiquitous, colorful foam clogs. EPA alleged that Crocs violated FIFRA by making unsubstantiated antimicrobial health claims on its website, in advertising, and on packaging for several styles of the Company’s shoes. Pursuant to the settlement agreement, Crocs will remove the offending language and pay a $230,000 penalty. The Company will undoubtedly incur significant additional expense to revise its advertising materials, field questions from distributors and worried customers, and take other steps necessary to ensure future compliance and help protect the Crocs brand. A copy of the settlement agreement is available here.
This case is another unfortunate example of the relative ignorance of many consumer products companies about the application of FIFRA to consumer products treated with antimicrobials or other pesticides. One would not normally consider shoes to be a pesticide product, but under FIFRA, they can be. Making an antimicrobial public health claim about a product (usually because of a chemical applied to the product) is one of the easiest ways to make a cutting board, computer keyboard, etc., subject to FIFRA. Many companies simply don’t understand this, or they mistakenly think their products qualify for the “treated articles” exemption and therefore they don’t need to worry about FIFRA. (More on the “treated articles” exemption in a minute.) EPA’s enforcement docket is littered with past examples of such mistakes.
Simply stated, products that claim to kill or repel bacteria or germs are considered pesticides under FIFRA. FIFRA requires companies to register pesticide products with EPA before selling, distributing, or making public claims about their ability to control germs or pathogens. The registration process can be time-consuming and expensive because EPA will not register a pesticide until it has been shown, through testing, not to pose an unreasonable risk when used according to the label’s directions.
Companies often aren’t aware of the scope of the registration requirement. Others are aware of it, but believe (mistakenly) that their products qualify for the “treated articles” exemption in 40 CFR 152.25(a). Eligibility for this exemption is not as straightforward as it might seem. In a nutshell, the exemption requires: (1) the incorporated pesticide to be registered for use in or on the article and (2) the sole purpose of the treatment to be protection of the article itself. Implied or explicit public health claims for protection against bacteria, fungi, viruses, or other pathogens (e.g., “antibacterial”) are prohibited since they show that treatment was not solely for protection of the article itself. Companies commonly make claims broader than those allowed or they fail to confirm that the registration covers treatment of their specific type of product. The result is a violation of FIFRA with all the pain and expense that entails.
Where does this leave a consumer products company wanting to capitalize on society’s germ phobia? Well, before succumbing to the sirens’ song from Marketing or Sales about the new marketing opportunities, usually an in-house counsel, product steward, or other EH&S professional inquires about FIFRA compliance. If shrugs or blank stares are returned, that person will arrest the momentum and probe the issue further. (Disclaimer: This is a practical observation and not legal advice.) EPA has helpful guidance , and other information is available on its website, here and here.